(Adds details, shares suspended)
PARIS, March 4 French company Carmat
said on Tuesday that it would proceed with further clinical
trials in humans of its artificial heart after the death of the
first patient fitted with the device.
Carmat's first patient, a 76-year-old man, died on Sunday in
Paris, two and a half months after his transplant.
When he was fitted with the device, the man was suffering
from terminal heart failure, when the sick heart can no longer
pump enough blood to sustain the body, and was said to have only
a few weeks, or even days, to live.
The hospital that had performed the operation said the cause
of his death could not be known for sure at this stage.
"Carmat, first and foremost, wishes to pay tribute to the
courage and the pioneering role of this patient and his family,"
the group said in a statement.
"The company stresses that it is too soon to draw any
conclusions from the data of a single patient, whatever the
duration of the implantation."
Carmat's bioprosthetic device is designed to replace the
real heart for as much as five years, mimicking nature's work
using biological materials and sensors. It aims to help the
thousands of patients who die each year while awaiting a donor,
and reducing the side-effects associated with transplants.
Carmat's heart is designed to serve not as a bridge to
transplant but as a permanent implant, extending life for
terminally ill patients who cannot hope for a real organ,
generally because they are too old and donors too scarce.
In an initial feasibility study, three more patients in
France with terminal heart failure were due to be fitted with
Carmat's device, which is designed to replace the real heart for
as much as five years. The clinical trial will be considered a
success if the patients survive with the implant for at least a
If it passes the test, Carmat has said it would fit the
device into about 20 patients with less severe heart failure.
Carmat said it was not planning to publish any information
on the results of the feasibility study until a global analysis
of the trial's data was completed.
Carmat shares have been suspended since Tuesday morning at
95 euros per share, giving the group a market capitalisation of
406 million euros. The firm did not say in its statement on
Tuesday when the shares would begin trading again.
Last year, Carmat posted a net loss of 14.6 million euros,
after a 17.2 million loss in 2012. In its half-year financial
report, it had an operating cash burn of 3.6 million euros.
The company has said it had enough cash and subsidies to
fund its activities until 2015. But it could seek an injection
of funds from fresh investors at some point to help fund its
international expansion, Carmat co-founder Philippe Pouletty
said in December.
(Reporting by Natalie Huet and Leila Abboud; Editing by William